MosaiQ AiPlex® Vasculitis assay now available for clinical use in the European Union and other CE mark accepting countries

AliveDx achieves IVDR-CE Mark for a multiplexed MosaiQ AiPlex^® Vasculitis (VAS) assay, designed to advance the testing of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides and Anti-GBM (Goodpasture's) disease and improve time to results to support diagnosis of autoimmune vasculitis.  

EYSINS, Switzerland, Aug. 4, 2025 /PRNewswire/ -- AliveDx, the global in vitro diagnostics company that aims to transform patient care, today announces that the MosaiQ AiPlex^® Vasculitis (VAS) assay achieved IVDR-CE Mark. This means that the MosaiQ AiPlex VAS assay is now available for clinical use in the European Union and other countries accepting the IVDR-CE mark.  

The MosaiQ AiPlex VAS assay is designed to improve time to results to support diagnosis of autoimmune vasculitis, while simplifying laboratory workflows. ANCA-associated vasculitides comprise three distinct syndromes - granulomatosis with polyangiitis (GPA, formerly known as Wegener's granulomatosis), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA, formerly known as Churg-Strauss syndrome). If left untreated, Anti-GBM disease can lead to life-threatening consequences. Vasculitides are complex conditions that cause inflammation of blood vessel walls, potentially leading to severe organ and tissue damage. It can present as a medical emergency and varies significantly by vessel size, organ involvement, and clinical symptoms, making timely and accurate diagnosis challenging.^1-7  

MosaiQ AiPlex^® VAS multiplex assay: Fast, Easy, Comprehensive  

The MosaiQ AiPlex VAS assay enables simplified serological evaluation (rule in or rule out) of autoimmune vasculitis for healthcare providers. Using only 10μl of patient serum, the test provides results for three key autoantibody markers - MPO, PR3, and GBM - in a single, comprehensive report. These markers are aligned with current clinical best practices, including the 2022 ACR/EULAR guidelines for managing ANCA-associated vasculitis^2-4 and KDIGO 2021 guideline for managing Glomerular Diseases.⁵ 

"Our MosaiQ technology provides multiplexed test results fully automated and at speed, which shortens time to results and supports accelerated diagnosis of autoimmune diseases, improving patient outcomes and reducing healthcare costs. Achieving IVDR-CE Mark approval is a major step forward in our mission to bring best-in-class healthcare solutions to clinicians, labs – and most of all, patients across Europe. This milestone confirms our commitment to meeting the highest standards of safety, performance, and quality with yet another panel in our portfolio," said Manuel O. Méndez, CEO of AliveDx.  

The intuitive MosaiQ solution has been designed to provide simple workflow, fast results and actionable insights through its high throughput, automated multiplexing capability. Combining multiple relevant markers into one single test enables actionable insights for better patient care, as well as reducing significant hands-on time and minimizing consumable usage. To further simplify laboratory workflows, internal calibration of each microarray is embedded at the point of manufacture, thus saving time in the lab. All reagents and multiplex microarray magazines are equipped with RFID tags to aid automation, save time while avoiding manual errors.   

About AliveDx  

At AliveDx, our mission is to empower diagnostic insights, transform patient care, and innovate for life. With over 30 years in in-vitro diagnostics, we are dedicated to shaping the future of global diagnostics in autoimmune, allergy, and beyond. Our groundbreaking solutions empower laboratories and clinicians to accelerate diagnosis, improving patients' lives while fostering a positive and sustainable work environment for healthcare providers. Our portfolio includes the Alba, MosaiQ and LumiQ brands. These solutions aim to generate both economic and clinical value by simplifying laboratory workflows and providing fast, accurate results that enhance clinical decision-making. At AliveDx, we innovate for life.  

About the MosaiQ solution  

The MosaiQ solution is a state-of-the-art IVD solution for autoimmune diseases, allergies and beyond. The multiplexed, fully automated planar microarray platform enables syndromic testing for complex conditions. This intuitive platform offers high throughput with continuous random access, delivering fast and accurate results addressing evolving expectations for laboratory efficiency.  

For more information about AliveDx and its solutions, please visit www.alivedx.com and connect with us on LinkedIn and X.  

©AliveDx Suisse SA. 2025. The AliveDx logo, AliveDx, MosaiQ, MosaiQ AiPlex, are trademarks or registered trademarks of AliveDx group companies in various jurisdictions. Menus and capabilities are subject to change. Not all methods may be available in all territories. Subject to regulatory clearance. This product is not currently available in the USA, cleared or approved by the U.S. Food and Drug Administration (FDA) for clinical use. 

¹ Treppo E et al. Systemic vasculitis: one year in review 2024.Clin Exp Rheumatol. 2024;42(4):771-781.  
² Robson JC et al. 2022 ACR/EULAR GPA Classification Criteria.Ann Rheum Dis. 2022;81(3):315–320.  
³ Suppiah R et al. 2022 ACR/EULAR MPA Classification Criteria.Ann Rheum Dis. 2022;81(3):321-326.  
⁴ Grayson PC et al. 2022 ACR/EULAR EGPA Classification Criteria.Ann Rheum Dis. 2022;81(3):309-314.  
⁵ KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021;100(4S):S1-S276.  
⁶ Ntatsaki E et al. BSR and BHPR guideline for the management of adults with ANCA-associated vasculitis. Rheumatology (Oxford).2014;53(12):2306-9.  
⁷ Hellmich B et al. EULAR recommendations for the management  
of ANCA-associated vasculitis: 2022 update. Ann Rheum Dis. 2024;83(1):30-47.   

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